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INCOSE Biomedical-Healthcare Working Group (BHWG) Model-Based Systems Engineering (MBSE) Challenge Team Meeting Monday, January 27, 2014 Steven Corns Ajay.

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Presentation on theme: "INCOSE Biomedical-Healthcare Working Group (BHWG) Model-Based Systems Engineering (MBSE) Challenge Team Meeting Monday, January 27, 2014 Steven Corns Ajay."— Presentation transcript:

1 INCOSE Biomedical-Healthcare Working Group (BHWG) Model-Based Systems Engineering (MBSE) Challenge Team Meeting Monday, January 27, 2014 Steven Corns Ajay Thukral Jack Stein

2 Biomedical-Healthcare Model-Based Systems Engineering (MBSE) Challenge Team Agenda – Introductions – (5 min) – Modeling Efforts – (10 min) – Industry Standards, Compliance, Assurance – (15 min) – Integration of Dr. Insup Lees work – (15 min) – MBSE Position Paper – (15 min) – Presentation by Drew Pihera 2

3 INTRODUCTIONS

4 BIOMEDICAL AND HEALTHCARE SYSTEM CHALLENGES

5 Biomedical-Healthcare Engineering and Application Environment Medical Devices Pharmaceuticals Healthcare Facilities and Equipment IT Systems / Medical Records Models, Analysis, & Simulations Standards & Regulations Technologies Health Systems Translation of Elements of Clinical Care 5

6 Biomedical-Healthcare System Solutions Each Biomedical-Healthcare System strives to be a preeminent leader in clinical care, education, research and service. These are measured by objective evidence and established best practices….." Vision that guides Biomedical-Healthcare Systems "If it can be measured, it can be managed [and improved] Jack Welch TRADITIONAL PRESSURES HEALTHCARE REFORM CMS / PAYERS ACCOUNTABLE CARE ORGS For full effectiveness, all the work needs to be integrated into a unified program for performance. Peter Drucker Hoshin Kanri KPIs Metrics Balance Scorecard PROCESS OPTIMIZATION Lean & Six Sigma …are we there? 6

7 Systems Challenges in the Biomedical- Healthcare Sectors Examples.… – Healthcare Cost Reduction – Electronic Health Records – Mobile Medical Apps - Remote & Telemedicine – Medical Device Interoperability – Counter Bioterrorism Coordination – Universal Healthcare Coverage – Your system challenges ? 7

8 Issues to be Addressed Time to adoption Ensure regulatory, compliance, and risk management requirements are met Cost reduction Consistency across device design Others? 8

9 MBSE CHALLENGE TEAM ADDRESSING SYSTEM CHALLENGES

10 INCOSE Biomedical-Healthcare Working Group (BHWG) MBSE Challenge Team One of over a dozen INCOSE MBSE Challenge and Activity Teams / Formed in 2011 Information is public domain (OMG MBSE Wiki Site) Current Modeling Project: – Infusion and Drug Delivery System (IDDS) Model Meetings – Regular teleconference WebEx meetings – Periodically face-to-face (Missouri S&T St. Louis Campus, INCOSE Conferences, and International Workshop) 10

11 Challenge Team Mission, Vision, Charter Mission: – Demonstrate the value and utility of MBSE for biomedical-healthcare related applications and programs – Provide INCOSE BHWG members a reference design to adopt for their specific drug, device, and/or biological product development efforts Project Overview: – Involve BHWG members in the use of MBSE thus expanding the application beyond defense and aerospace industry related projects. – Develop frameworks and templates that can be used to accelerate the development and approval of biomedical devices. – Investigate the integration of risk management, safety assurance, and other aspects related to the regulatory environment. – Provide a forum for learning how to make the shift from a document- centric to a model-centric systems engineering environment 11

12 Vision – Enabling Excellence in Biomedical- Healthcare System Engineering Infusion and Drug Delivery System (IDDS) Model Risk Assessment / Safety Assurance Analysis Structures Generic Models: -Infusion Pump -ICE (ASTM F2671) Standards Regulations Other publications LIBRARY Standard Interfaces Reusable Elements Other Development Systems and Tools 12

13 Project Status / Team Development Recent Activities: – MBSE short course for working group and MBSE team members – Preliminary framework created – Wiki site updated to share information on progress – Met with University of Pennsylvania Challenge Team – All members are welcome (General Interest, Modeler, Leadership/Admin Roles) – Willingness to meet with bi-weekly to review model / Complete actions items – Contact a MBSE initiative member in the BHWG Steven Corns (cornss@mst.edu)cornss@mst.edu Sandy Friedenthal (safriedenthal@gmail.com)safriedenthal@gmail.com Jack Stein (jack.stein@me.com)jack.stein@me.com Ajay Thukral (ajay.thukral@cientivegroup.com)ajay.thukral@cientivegroup.com 13

14 MBSE CHALLENGE TEAM MODELING EFFORTS

15 Domain

16 Requirements

17 Device Description

18 System Procurement

19 Method for Addition of Parametrics

20 MBSE CHALLENGE TEAM INDUSTRY STANDARDS, COMPLIANCE AND ASSURANCE

21 Addressing Risk Up Front Risk tolerance typically lower in medical devices Risk management a key element in device clearance/approval. New Safety Assurance practices and documentation likely (Infusion Pumps). Device clearance/approval is tightly linked to compliance with standards and regulations – ISO 14971 (Risk Management) – IEC 62366 (Usability Engineering) – ISO 62304 (Software Life Cycle) – IEC 60601 (Electrical Safety) – FDA Design Controls (Needs, Requirements, V&V, etc.) 21

22 Vision – Enabling Excellence in Biomedical- Healthcare System Engineering Infusion and Drug Delivery System (IDDS) Model Risk Assessment / Safety Assurance Analysis Structures Generic Models: -Infusion Pump -ICE (ASTM F2671) Standards Regulations Other publications LIBRARY Standard Interfaces Reusable Elements Other Development Systems and Tools 22

23 Integrated Clinical Environment (ICE) Medical Device Plug-and-Play Interoperability Getting Connected for Safety 23

24 ASTM F2671 Integrated Clinical Environment (ICE) Figure 1 from ASTM F2671 – Conceptual functional model showing the elements of ICE 24

25 Bring Standards Directly Into the Design/Development Environment: Example – ASTM F2671 ICE (Interoperability) Transform information in standards into integrated model elements, configurations, and views which are directly traceable to use scenarios, requirements, architecture, verification, validation, risk management, safety assurance, and other information. 25

26 SysML Representation of the ASTM F2671 Integrated Clinical Environment (ICE) Model 26

27 Model-Driven Safety Analysis of Closed- Loop Medical Systems – Dr. Insup Lee

28 Overview Model of a patient controlled analgesia (PCA) pump Allows for model with a patient in the loop Create a model that incorporates this devices with higher level system

29 Patient Model

30 Drug Model

31 Model and Environment

32 PCA Pump verification

33 Moving Forward

34 What do we want to accomplish this year?

35 Vision – Enabling Excellence in Biomedical- Healthcare System Engineering Infusion and Drug Delivery System (IDDS) Model Risk Assessment / Safety Assurance Analysis Structures Generic Models: -Infusion Pump -ICE (ASTM F2671) Standards Regulations Other publications LIBRARY Standard Interfaces Reusable Elements Other Development Systems and Tools 35

36 Goals Guidelines for using the framework developed Expansion of library of components and methods Continue integration of ISO/IEC standards and compliance Others?

37 Discussion

38 Copied from Sandford Friedenthal presentation 38

39 From Document-Centric to Model-Centric 39

40 Object-Oriented (MBSE) SE Approach Traceability 40

41 Our OMG Wiki Page (Public) http://www.omgwiki.org/MBSE/doku.php?id=mbse:drugdelivery 41


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